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Ambrisentan

Volibris

Extended indication Extension application to introduce a new strength (2.5 mg film-coated tablet), grouped with an exten
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Ambrisentan
Domain Lung diseases
Reason of inclusion Indication extension
Main indication Lung diseases other
Extended indication Extension application to introduce a new strength (2.5 mg film-coated tablet), grouped with an extension of indication to include treatment of PAH in adolescents and children (8 to less than 18 years).
Proprietary name Volibris
Manufacturer GSK
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration September 2021
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP opinie juli 2021.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation betreft een indicatie-uitbreiding naar kinderen en adolescenten.

Expected patient volume per year

References ntvg.nl
Additional remarks De prevalentie van PAH in Nederland is ongeveer 15-52 per 1 miljoen inwoners. Gezien het een pediatrische uitbreiding betreft zal slecht een klein deel ven de patiënten in aanmerking komen.

Expected cost per patient per year

References medicijnkosten.nl, GIP databank
Additional remarks Prijs per tablet van 5mg per stuk €52,32 exclusief afleverkosten en inclusief BTW. Prijs per tablet van 10mg per stuk €83,70 exclusief afleverkosten en inclusief BTW. De vergoeding per gebruiker in 2020 betrof €22.243.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Adis Insight

Other information

There is currently no futher information available.